WuXi stock plum­mets, wip­ing near­ly $10B off mar­ket val­ue as US adds it to ‘un­ver­i­fied’ list

As Covid-19 has made it more dif­fi­cult for US reg­u­la­tors to car­ry out rou­tine in­spec­tions, WuXi Bi­o­log­ics has been hit with un­ver­i­fied sta­tus, caus­ing its stock to plum­met, and wipe $9.9 bil­lion off of its mar­ket val­ue be­fore trad­ing of its shares was halt­ed.

WuXi’s stock tum­bled 26% in Hong Kong af­ter the com­pa­ny was added to the US De­part­ment of Com­merce’s un­ver­i­fied list. The com­pa­nies on the list are hit with stricter im­port con­trols. WuXi is list­ed right on page 7 of the re­port, along with an­oth­er 70-plus com­pa­nies based in Chi­na. The list­ing means that it is un­able to re­ceive items sub­ject to the ex­port ad­min­is­tra­tion reg­u­la­tions, and ex­porters on the list must file an Au­to­mat­ed Ex­port Sys­tem record.

This list­ing does not mean that the com­pa­ny has been black­list­ed — an in­for­mal term for a list of com­pa­nies that US in­vestors are barred from own­ing shares in, or mov­ing shares they al­ready have — and the com­pa­ny made sure that was known in a state­ment it re­leased Mon­day.

“We un­der­stand that the rea­son for this ac­tion is be­cause U.S. gov­ern­ment agen­cies have not been able to un­der­take re­quired end-use ver­i­fi­ca­tions in or­der for cer­tain equip­ment to be ex­port­ed from US sup­pli­ers,” it said. “The ‘Un­ver­i­fied List’ is not the US ‘En­ti­ty List’ or ‘Black List’ that are more well known.”

WuXi has been im­port­ing hard­ware con­trollers for biore­ac­tors and hol­low fiber fil­ters that are sub­ject to US ex­port con­trol for the last 10 years and says that it has been in com­pli­ance with reg­u­la­tions ever since. But the De­part­ment of Com­merce’s ver­i­fi­ca­tion process has not been able to take place in the last two years thanks to Covid-19, and that is enough to land on the un­ver­i­fied list.

“This has no im­pact on our busi­ness or on­go­ing ser­vices to glob­al part­ners. There is very min­i­mal im­pact to our im­ports as no such equip­ment is re­quired af­ter fa­cil­i­ty con­struc­tion in Shang­hai and Wuxi,” the state­ment said. “We wel­come in­spec­tion at any time for the clear­ance and re­moval from such list. We are al­so pur­su­ing in­ter­im mea­sures to re­move these sub­sidiaries from the list pri­or to in­spec­tion.”

The stock slide comes as a bit of a re­turn to Earth for the com­pa­ny that had ex­pe­ri­enced such strong suc­cess in re­sponse to the de­mand for Covid-19 vac­cine man­u­fac­tur­ing. A re­port from CPhI in No­vem­ber said that along with Lon­za, Sam­sung and Fu­ji­film Diosynth Biotech­nolo­gies, WuXi would have the largest man­u­fac­tur­ing ca­pac­i­ty in the world by 2025, so long as trends con­tin­ue in the same di­rec­tion.

It al­so opened up a mas­sive ex­pan­sion at its Wuxi, Chi­na head­quar­ters, adding an eighth drug pro­duc­tion fa­cil­i­ty and the ca­pac­i­ty to bring 60 mil­lion vials a year of com­mer­cial drug pro­duc­tion.  The 129,166-square-foot fa­cil­i­ty is called DP2 and has an iso­la­tor fill­ing line for con­tin­u­ous pro­duc­tion, which will elim­i­nate cross-con­t­a­m­i­na­tion.

In to­tal, 33 Chi­nese com­pa­nies have been added to the un­ver­i­fied list. DOC as­sis­tant sec­re­tary for ex­port en­force­ment Matthew Ax­el­rod said in a state­ment that the ver­i­fi­ca­tion process is a core prin­ci­ple for the con­trol sys­tem. The ad­di­tion of those com­pa­nies to the list “will as­sist U.S. ex­porters in con­duct­ing due dili­gence and as­sess­ing trans­ac­tion risk, and sig­nal to the PRC gov­ern­ment the im­por­tance of their co­op­er­a­tion in sched­ul­ing end-use checks.”

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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